Търсене на изпитвания

Активни:

Намерени 3,079 изпитвания Стр. 63 от 154

Набира участници

The ARRC III Trial of Advanced Recovery Room Care (ARRC).

Post-Surgical Complication Economic Problems

A postoperative high-acuity model of care (ARRC) has been shown, in a prospective cohort study of approximately 850 patients, to produce a marked improvement in patient and hospital outcomes, and hospital costs, in medium risk patients (Ludbrook G et al., JAMA Surgery 2023). The goal of this observational study is to examine the outcomes after non-cardiac surgery of a larger group of medium risk patients receiving different forms of care -ARRC and usual ward care. The main questions it aims to answer are: what are the outcomes for patients and hospital after the different forms of care, who receives benefit from high acuity care, what underlies the improved outcomes seen with high acuity care.

Начало: 18.04.2023 Край: 01.12.2025 Възраст: от 18 г.

Australia University of Adelaide NCT05836285

Набира участници

Comparison of the Outcomes of Single vs Multiple Arterial Grafts in Women

Heart Diseases Coronary Artery Disease Coronary Artery Bypass Grafting

The central hypothesis of ROMA:Women is that the use of multiple arterial grafting (MAG) will improve clinical outcomes and quality of life (QOL) compared to single arterial grafting (SAG). The specific aims of ROMA:Women are: Aim 1: Determine the impact of MAG vs SAG on major adverse cardiac and cerebrovascular events in women undergoing coronary artery bypass grafting (CABG). The investigators will compare major adverse cardiac and cerebrovascular events (death, stroke, non-procedural myocardial infarction, repeat revascularization, and hospital readmission for acute coronary syndrome or heart failure) in a cohort of 2,300 women randomized 1:1 to MAG or SAG. Differences by important clinical and surgical subgroups (patients younger or older than 70 years, diabetics, racial and ethnic minorities, on vs off pump CABG, type of arterial grafts used) will also be evaluated. The women enrolled in the ongoing ROMA trial (anticipated to be approximately 690) will be included in ROMA:Women, increasing efficiency and reducing enrollment time. Hypothesis 1.0. MAG will reduce the incidence of major adverse cardiac and cerebrovascular events. Hypothesis 1.1. The improvement with MAG will be consistent across key subgroups. Aim 2: Determine the impact of MAG vs SAG on generic and disease-specific QOL, physical and mental health symptoms in women undergoing CABG. The investigators will compare generic (SF-12, EQ-5D) and disease-specific (Seattle Angina Questionnaire) QOL and physical and mental health symptoms (PROMIS-29) in a sub-cohort of 500 women randomized 1:1 to MAG or SAG (including those enrolled in ROMA:QOL). Differences by important subgroups (as defined above) will also be evaluated. Hypothesis 2.0. MAG will improve generic and disease-specific QOL compared to SAG. Hypothesis 2.1. MAG will improve physical and mental health symptoms compared to SAG. Hypothesis 2.2. The improvement with MAG will be consistent across key subgroups.

Начало: 17.04.2023 Край: 01.03.2030 Възраст: от 18 г. Лечение

Australia, Brazil, Canada +20 Weill Medical College of Cornell University NCT04124120

Набира участници Фаза 2

MNK Inhibitor AUM001 in Combination With Either Pembrolizumab or Irinotecan to Treat Metastatic Colorectal Cancer

Metastatic Colorectal Cancer

The study is a 2-part study of Tinodasertib alone or in combination with Pembrolizumab/Irinotecan in patients with CRC.

Начало: 14.04.2023 Край: 15.10.2026 Възраст: от 18 г. Лечение

Australia AUM Biosciences Pte Ltd NCT05462236

Набира участници Фаза 2

MEKTOVI® for the Treatment of Pediatric Adamantinomatous Craniopharyngioma

Adamantinous Craniopharyngioma Recurrent Adamantinomatous Craniopharyngioma

MEKTOVI (binimetinib) is an oral, highly selective reversible inhibitor of mitogen-activated extracellular signal regulated kinase 1 (MEK1) and MEK2. The biological activity of binimetinib that has been evaluated bith in vitro and in vivo in a wide variety of tumor types In this Phase II, the drug will be used to treat pediatric patients diagnosed with recurrent Adamantinomatous Craniopharyngioma including patients who have undergone surgery and/or radiation therapy.

Начало: 10.04.2023 Край: 10.04.2027 Възраст: 1–39 г. Лечение

Australia, Canada, United States Nationwide Children's Hospital NCT05286788

Набира участници Фаза 2/3

A Study of TAK-861 for the Treatment of Selected Central Hypersomnia Conditions

Narcolepsy Type 1

The main aim is to evaluate the safety and tolerability of TAK-861 in participants with type 1 narcolepsy, who were exposed to previously tested doses of TAK-861.

Начало: 05.04.2023 Край: 28.02.2028 Възраст: 16–70 г. Лечение

Australia, Finland, France +8 Takeda NCT05816382

Набира участници Фаза 1

Study to Evaluate Adverse Events and Change in Disease Activity in Adult Participants With B-Cell Malignancies Receiving Oral ABBV-525 Tablets

Diffuse Large B-Cell Lymphoma Chronic Lymphocytic Leukemia B Cell Malignancies Non-Hodgkin's Lymphoma

B-cell malignancies are a group of cancers of B lymphocytes, a type of white blood cell responsible for fighting infections. The purpose of this study is to assess safety, tolerability, pharmacokinetics and preliminary efficacy of ABBV-525 as a monotherapy. ABBV-525 is an investigational drug being developed for the treatment of B-Cell Malignancies. Study doctors put the participants in groups called treatment arms. Participants will receive ABBV-525 at different doses. Approximately 150 adult participants will be enrolled in the study across sites worldwide. In part 1 (dose escalation), participants will receive escalating oral doses of ABBV-525. In part 2 (dose optimization), participants will receive one of two oral doses of ABBV-525, until the recommended phase 2 dose (RP2D) is determined. In part 3 (dose expansion), participants will receive the RP2D oral dose of ABBV-525. The estimated duration of the study is up to 64 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.

Начало: 04.04.2023 Край: 01.07.2029 Възраст: от 18 г. Лечение

Australia, Belgium, France +7 AbbVie NCT05618028

Набира участници Фаза 1/2

A First-in-human Study of IBI354 in Subjects with Locally Advanced Unresectable or Metastatic Solid Tumors

Locally Advanced Unresectable or Metastatic Solid Tumors

This is a Phase 1/2, open-label, multicenter study designed to evaluate the safety, tolerability, and DLTs to establish the maximum tolerated dose (MTD) or maximum administered dose (MAD), and the RP2D of sequential doses of IBI354 (study drug), and to explore and confirm the efficacy, safety and tolerability of IBI354 in subjects with locally advanced unresectable or metastatic solid tumors.

Начало: 04.04.2023 Край: 31.10.2025 Възраст: от 18 г. Лечение

Australia, China Innovent Biologics (Suzhou) Co. Ltd. NCT05636215

Набира участници Фаза 1

131I-TLX-101 for Treatment of Newly Diagnosed Glioblastoma (IPAX-2)

Neoplastic Disease Glioblastoma Glioblastoma Multiforme

This is an open label, single arm, parallel-group, multicentre, and dose finding study to evaluate the safety of ascending radioactive dose levels of 131I-TLX101 administered intravenously in combination with best standard of care in newly diagnosed GBM patients.

Начало: 01.04.2023 Край: 01.06.2026 Възраст: от 18 г. Лечение

Australia, Netherlands Telix Pharmaceuticals (Innovations) Pty Limited NCT05450744

Набира участници Фаза 3

A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy

Breast Cancer, Early Breast Cancer

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard endocrine therapy in patients with ER+/HER2 - early breast cancer with intermediate or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy) and standard adjuvant endocrine therapy (ET) for at least 2 years and up to 5 years. The planned duration of treatment in either arm of the study is 60 months.

Начало: 31.03.2023 Край: 29.05.2036 Възраст: 18–130 г. Лечение

Argentina, Australia, Belgium +34 AstraZeneca NCT05774951

Набира участници Фаза 1/2

A Trial to Evaluate EP-104GI in Adults With Eosinophilic Esophagitis (EoE).

Eosinophilic Esophagitis

A Phase 1b/2 study to explore the safety, efficacy and pharmacokinetics of EP-104GI in adults with eosinophilic esophagitis (EoE). Endoscopic and histologic assessments will also be evaluated to understand the local effects of EP-104GI on eosinophilic EoE disease activity. Approximately 27 to 33 participants will be enrolled in dose escalation: 3-6 participants per dose cohort. The number of participants enrolled in escalation will depend on the number of dose escalation cohorts evaluated, and dose cohorts needing to be expanded. An additional 10-24 participants will be enrolled in 1 or 2 cohorts of 10-12 participants each at tolerable dose regimen(s) selected based on the accumulated clinical data to identify the recommended phase 2 dose(s) (RP2D). In the Phase 2 randomized dose optimization portion of the study, approximately 120 subjects will be randomized to Dose A (120 mg total dose), Dose B (160 mg total dose), or matching vehicle control, with an overall assignment ratio of 1:1:1. The total number of participants in both portions of the study will be approximately 160. The study involves 8-10 site visits spread over approximately 52 weeks. Participants in an extended PK sub study will have up to 4 additional visits, to a maximum of 108 weeks post-dose. The participants will either receive the active study drug (EP-104GI) or matching vehicle control. Matching vehicle control will be used only in randomized dose optimization portion of the study. Participants randomized to receive vehicle control may receive EP-104GI (Dose A or Dose B) following the completion of Week 24 providing they meet eligibility criteria for crossover to EP-104GI. Participants randomized to receive EP-104GI on Day 0 will not receive EP-104GI or vehicle control at Week 24. The study drug or matching vehicle control will be administered by qualified personnel during an esophagogastroduodenoscopy (EGD) procedure at the Baseline/Dosing visit. Safety will be assessed throughout the study. Blood and urine samples will be collected at site visits for laboratory assessments and to measure plasma levels of EP-104GI. Participants will complete questionnaires to assess symptoms of dysphagia and odynophagia and will undergo 3-5 EGDs with esophageal biopsies at the Baseline, Week 4 (dose escalation phase only), Week 12, Week 24 (randomized dose optimization phase only), Week 26, and Week 52 (randomized dose optimization phase only).

Начало: 31.03.2023 Край: 01.12.2026 Възраст: 18–75 г. Лечение

Australia, Canada, Netherlands +3 Eupraxia Pharmaceuticals Inc. NCT05608681

Набира участници Фаза 3

Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanoma.

Metastatic Melanoma Unresectable Melanoma Melanoma

This is a Phase 3, multicenter, open-label, randomized, parallel group, treatment study to assess the efficacy and safety of lifileucel in combination with pembrolizumab compared with pembrolizumab alone in participants with untreated, unresectable or metastatic melanoma. Participants randomized to the pembrolizumab monotherapy arm who subsequently have a blinded independent central review- verified confirmed progressive disease (PD) will be offered lifileucel monotherapy in an optional crossover period.

Начало: 30.03.2023 Край: 01.03.2030 Възраст: 18–70 г. Лечение

Australia, Belgium, Canada +10 Iovance Biotherapeutics, Inc. NCT05727904

Набира участници

Risk-guided Disease Management Plan to Prevent Heart Failure in Patients Treated With Previous Chemotherapy (REDEEM)

Heart Failure

This is a prospective study in which a process of identifying and reducing heart failure (HF) risk will be applied to cancer survivors \>55 years old with chemotherapy \>5 years ago. The overall goal of this study to identify the feasibility and value of risk-guided cardiac rehabilitation (exercise, risk factor modification, and behavioural support) as a component of survivorship care.

Начало: 30.03.2023 Край: 31.12.2025 Възраст: 40–85 г. Скрининг

Australia Baker Heart and Diabetes Institute NCT04962711

Набира участници

Surface Monitoring Technology to Remove The Mask - Stage 1

Head and Neck Cancer Radiation Therapy Complication Anxiety

A pilot-stage device feasibility study investigating a mask-free motion-monitoring patient immobilisation system for use during radiation therapy treatment of head and neck cancer (HNC). This mask-free system combines the standard radiation therapy (RT) head rest to help the patient remain still with a surface guidance detection system that uses sensors to detect and track patient movement. Patients who will have RT treatment for head and neck cancer involving an immobilisation mask will be asked to lie on the treatment couch for the normal treatment fraction time while the surface monitoring system is activated. We will then assess: i) The level of acceptance of the system by HNC patients currently being treated with RT using an immobilisation mask, and ii) The ability of the surface guidance system to monitor movement of the patients

Начало: 28.03.2023 Край: 01.12.2024 Възраст: от 18 г. Устройства

Australia University of Sydney NCT04266223

Набира участници

Total Intravenous Anesthesia (TIVA)/Sevoflurane Initiated Intravenous Anesthesia (SIIVA) in Pediatric Patients

Extubation

Because Propofol is the primary "anesthetic agent," and inhalational agents remain in trace quantities at the end of the procedure Sevoflurane initiated intravenous anesthesia (SIIVA) or not present at all Total intravenous anesthesia (TIVA) it is likely that different criteria may be predictive of extubation success in these patients compared to inhalational anesthesia.

Начало: 28.03.2023 Край: 01.03.2028 Възраст: до 9 г.

Australia, United States Wake Forest University Health Sciences NCT05837936

Набира участници Фаза 1/2

Open-Label Study to Evaluate the Safety, Tolerability, PK, and Efficacy of INX-315 in Patients With Advanced Cancer

Breast Cancer Breast Cancer Metastatic Hormone Receptor Positive Tumor Human Epidermal Growth Factor 2 Negative Carcinoma of Breast +5

Incyclix Bio (Incyclix) is developing INX-315 as an oral, small molecule inhibitor of cyclin dependent kinase 2 (CDK2) for the treatment of human cancers. This first-in-human study is designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary antitumor activity of INX-315 in patients with recurrent advanced/metastatic cancer, including hormone receptor positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) breast cancer who progressed on a prior cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) regimen, and CCNE1-amplified solid tumors who progressed on standard of care treatment. The study will be conducted in 3 parts: Part A (INX-315 monotherapy dose escalation and combination therapy with fulvestrant), Part B (ovarian cancer INX-315 monotherapy dose expansion), and Part C (INX-315 combination therapy with abemaciclib \[a CDK4/6i\] and fulvestrant \[a SERD\] in advanced/metastatic breast cancer; dose escalation and expansion).

Начало: 28.03.2023 Край: 01.09.2027 Възраст: от 18 г. Лечение

Australia, United States Incyclix Bio NCT05735080

Набира участници Фаза 1

A Study of ATG-022 in Patients With Advanced/Metastatic Solid Tumors

Advanced/Metastatic Solid Tumors

This is an Open, Multi-center, Phase I Clinical Study of ATG 022 in Patients with Advanced/metastatic Solid Tumors

Начало: 27.03.2023 Край: 30.12.2027 Възраст: от 18 г. Лечение

Australia, China Antengene Biologics Limited NCT05718895

Набира участници Фаза 2

A Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures

Neonatal Seizure Neonatal Encephalopathy Hypoxic-Ischemic Encephalopathy Seizure Newborn

The main purpose of this study is to determine the maximum safe tolerated dose of LEV in the treatment of neonatal seizures. Our hypothesis is that optimal dosing of Levetiracetam (LEV) to treat neonatal seizures is significantly greater than 60mg/kg. This study will be an open label dose-escalation, preliminary safety and efficacy study. There will be a randomized control treatment component. Infants recognized as having neonatal seizures or as being at risk of developing seizures will be recruited and started on continuous video EEG monitoring (CEEG). Eligibility will be confirmed and consent will be obtained. In the first 2 phases of the study, neurologists will identify neonates with mild-moderate seizure burden (less than 8 minutes cumulative seizure activity per hour), appropriate for study with LEV, and exclude patients with higher seizure burden where treatment with PHB is more appropriate. Phase 3 of the dose escalation will only proceed if additional efficacy of LEV has been demonstrated in phases 1 and 2. In Phase 3 we will recruit neonates with seizures of greater severity up to 30 minute seizure burden/hour. This will make the final results of study more generalizable. If seizures are confirmed, enrolled subjects will receive 60mg/kg of LEV. Subjects whose seizures persist or recur 15 minutes after the first infusion is complete, subjects will then be randomized in the dose escalation study. Patients in the dose escalation study will be randomly assigned to receive either higher dose LEV or treatment with the control drug PHB in a 3:1 allocation ratio, stratified by site. Funding Source- FDA OOPD

Начало: 24.03.2023 Край: 31.12.2027 Възраст: до 1 г. Лечение

New Zealand, United States University of California, San Diego NCT05610085

Набира участници

Minimising Adverse Drug Reactions and Verifying Economic Legitimacy in Children (MARVEL-PIC)

Neoplasms Bone Marrow Transplantation

A prospective, open, randomised implementation study in paediatric cancer patients. The study aims to determine whether a personalised approach will result in an overall reduction in clinically relevant adverse drug reactions (ADRs) and to evaluate the economic and quality of life impacts. Participants will be randomised to receive personalised guided prescribing of supportive care therapy (study arm) or standard of care (control arm) for a period of 12 weeks. The follow up period includes prospective patient reporting of symptoms and quality of life through electronically delivered surveys, for a maximum of 12 months.

Начало: 22.03.2023 Край: 01.08.2027 Възраст: до 18 г. Поддържаща грижа

Australia Murdoch Childrens Research Institute NCT05667766

Набира участници

Multicenter Evaluation of Near Vision and Outdoor Time in Kids Study

Myopia

Currently, optical and pharmacological interventions have been developed to prevent the progression of childhood myopia. However, no myopia control strategy has been shown to have complete efficacy in controlling myopia progression in children. One possible reason is that risk factors contributing to the development of myopia were not controlled in previous clinical studies including time outdoors and near vision behaviour. This study aims to quantify time spent outdoors and near vision behavior in myopic children and its impact on myopia control efficacy. The outcomes of this study will guide clinicians on risk management and improve responses to existing treatments for progressive myopia.

Начало: 21.03.2023 Край: 31.12.2026 Възраст: 4–14 г.

Australia, United States The University of New South Wales NCT06119243

Набира участници Фаза 1

Study to Assess Amphotericin B Cystetic for Inhalation (ABCI) Doses in Healthy Volunteers & People with Cystic Fibrosis

Cystic Fibrosis

This is a 3-part, single-ascending dose Phase 1a randomized, double-blind, placebo-controlled study in healthy volunteers (Part A) and multiple-ascending dose Phase 1a randomized, double-blind, placebo-controlled study in healthy volunteers (Part B), and a Phase 1b open-label study in subjects with CF (Part C) to assess the safety, tolerability, PK, and preliminary efficacy of ABCI. Subjects will be evaluated for eligibility during Screening within 30 days prior to Day 1 (Randomization; Visit 3). In Parts A and B, eligible healthy volunteers may be enrolled in the study and randomly allocated to treatment with ABCI or placebo as described below. In Part C, eligible subjects with CF may be enrolled in the study and receive treatment with ABCI as described below. Approximately 72 healthy subjects total will be randomized to 9 cohorts (48 subjects in 6 cohorts in Part A, 24 subjects in 3 cohorts in Part B) and approximately 36 subjects with CF will receive the low dose, medium dose (2 sentinel subjects), or high dose of ABCI in Part C.

Начало: 21.03.2023 Край: 01.12.2025 Възраст: от 16 г. Лечение

Australia, New Zealand Cystetic Medicines, Inc. NCT05802264

1 … 61 62 63 64 65 … 154